Bayer ‘disappointed’ with FDA
pharmafile | February 18, 2014 | News story | Sales and Marketing | ACS, Bayer, Xarelto, blood, rivaroxaban
Bayer HealthCare has expressed its dismay after the Food and Drug Administration once again rejected further indications for the company’s blood thinner Xarelto.
Bayer and its development partner Janssen Research & Development had hoped that the licence of Xarelto (rivaroxaban) could be extended to treat patients with heart problems.
They wanted Xarelto 2.5 mg twice-daily, in combination with standard antiplatelet therapy, to be approved to reduce the risk of thrombotic cardiovascular events and stent thrombosis in patients with acute coronary syndrome (ACS).
But the FDA has previously expressed doubts about this, and two new complete response letters from the US regulator have dashed these hopes once more.
“We are disappointed with the outcome of the review,” admitted Jörg Möller, Bayer’s head of global development. But he said both firms were “committed to providing ACS patients in the US with additional protection against stent thrombosis and life-threatening thrombotic cardiovascular events”.
The uncommon condition occurs when blood pools at the site of stents implanted in patients’ coronary arteries – about 1.5 million people have these fitted each year and complications with potentially serious consequences, such as heart attack or death, can result.
ACS happens when a coronary artery is blocked by a blood clot, disrupting blood supply in a way which may lead to heart attack – or unstable angina, a condition which often presages an attack.
Xarelto already has half a dozen indications and in May last year the European Commission approved it for the prevention of atherothrombotic events – cardiovascular death, myocardial infarction or stroke – after an ACS in adult patients with elevated cardiac biomarkers.
The 2.5 mg twice-daily dose is co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Xarelto can be used to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF), plus the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and their recurrence.
The drug is also an option to prevent venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery.
Adam Hill
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